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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 63-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-6887969-9/1/1 28-Jun-2005 63ADB02 3004464238 Dr. Reddy's Laboratories Limited India
 
112-6364582-2/1/1 03-Jun-2005 63BDQ25 3002807086 GlaxoSmithKline Inc. Canada
 
112-6289080-9/1/1 01-Jun-2005 63HBK15 3005023028 San Jose Colombia
 
112-6621739-7/2/1 28-Jun-2005 63ICA01 3004879799 Roemmers Sa Dominican Republic
 
BDC-0005126-5/3/1 20-Jun-2005 63RAJ05 3003968961 Nikuy Ha Galil 1991 Ltd Israel
 
101-6824497-7/1/1 15-Jun-2005 63RAJ99 1000249755 Balsara Hygiene Products Ltd. India
 
101-6824497-7/1/2 15-Jun-2005 63RAJ99 1000249755 Balsara Hygiene Products Ltd. India
 
101-6824497-7/1/3 15-Jun-2005 63RAJ99 3003715595 Meena Exporters India
 
101-6824497-7/1/6 15-Jun-2005 63RAJ99 3001413302 Dabur India Limited India
 
113-2966719-7/1/1 21-Jun-2005 63RAS04 3003085221 Sunlit Fluo & Chemical Co. Ltd Taiwan
 
368-0260197-5/1/1 10-Jun-2005 63RBJ04 3005004526 Paglieri Sell System S.p.A. Italy
 
368-0260197-5/1/7 10-Jun-2005 63RBJ04 3005004526 Paglieri Sell System S.p.A. Italy
 
368-0260197-5/1/5 10-Jun-2005 63RBJ04 3005004526 Paglieri Sell System S.p.A. Italy
 
368-0260197-5/1/4 10-Jun-2005 63RBJ04 3005004526 Paglieri Sell System S.p.A. Italy
 
368-0260197-5/1/8 10-Jun-2005 63RBJ04 3005004526 Paglieri Sell System S.p.A. Italy
 
368-0260197-5/1/3 10-Jun-2005 63RBJ04 3005004526 Paglieri Sell System S.p.A. Italy
 
368-0260197-5/1/2 10-Jun-2005 63RBJ04 3005004526 Paglieri Sell System S.p.A. Italy
 
368-0260197-5/1/6 10-Jun-2005 63RBJ04 3005004526 Paglieri Sell System S.p.A. Italy
 
101-6824497-7/1/4 15-Jun-2005 63RBY04 3001061254 The Calcutta Chemicals Co India
 
101-6824497-7/1/5 15-Jun-2005 63RBY04 3001061254 The Calcutta Chemicals Co India
 
M76-3018402-7/1/1 08-Jun-2005 63RCL99 3000166001 Germiphene Corporation Canada
 
N02-0111555-2/1/15 24-Jun-2005 63VAJ99 3001605740 Dr. Juga Ltd Hungary
 
N02-0111555-2/1/16 24-Jun-2005 63VAJ99 3001605740 Dr. Juga Ltd Hungary
 
N02-0111555-2/2/8 24-Jun-2005 63VAJ99 3001605740 Dr. Juga Ltd Hungary
 
N02-0111555-2/7/19 24-Jun-2005 63VAJ99 3001605740 Dr. Juga Ltd Hungary
 
AEK-6571276-8/1/1 10-Jun-2005 63XCA99 3005165471 Chongkundang Farm Co Korea, Republic Of (South)
 
AEK-6581770-8/1/1 30-Jun-2005 63XCY99 3005195306 Gracheva Russia
 
112-7189430-5/1/1 14-Jun-2005 63XDA99 3004612060 Bri Biopharmaceutical Research Canada
 
112-6983483-4/1/1 06-Jun-2005 63XDY99 3005123855 Pharmacutical Laboratories India
 
112-7148508-8/1/1 10-Jun-2005 63XDY99 3004464238 Dr. Reddy's Laboratories Limited India
 
112-7148508-8/2/1 10-Jun-2005 63XDY99 3005147969 Mac'S Pharmaceuticals Jamaica
 
112-7148508-8/3/1 10-Jun-2005 63XDY99 3002628529 Pharmascience Inc. Canada
 
112-7191249-5/1/1 22-Jun-2005 63XDY99 3000264888 Patheon Inc. - Toronto Region Operations Canada
 
112-7157036-8/1/1 17-Jun-2005 63XIY99 3004735402 Ashwini Reanl Care Pvt India
 
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